On September 18, the act on medical products will come into force. Thus, there is less and less time for importers and distributors of medical products on the Polish market to get acquainted with the new act.

Among others, the legislator imposed on each importer or distributor of medical products who introduces a medical product for the first time in the Republic of Poland an obligation to notify the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Besides, charges were introduced for the so-called “free sales certificates” or “export certificates”, i.e. documents which are required to export medical products outside the EU. The act also broadens the scope of clinical tests and introduces a fee to be paid to the President of the Office in case of changes in a clinical test.

Contact person: Lech Gniady, lg@pnplaw.pl